Condition category
Surgery
Date applied
26/09/2005
Date assigned
26/09/2005
Last edited
11/12/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Lucia Gagliese

ORCID ID

Contact details

Department of Anaesthesia
Toronto General Hospital
200 Elizabeth Street
Toronto
M5G 2C4
Canada
+1 416 340 4296
lucia.gagliese@uhn.on.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MCT-52682

Study information

Scientific title

Acronym

Study hypothesis

Our primary aim is to determine whether perioperative NMDA-receptor antagonism has differential effects on postoperative pain, hyperalgesia and morbidity in younger and older patients. In order to achieve this aim, we propose to conduct the first randomized, double-blind placebo-controlled study designed to investigate age differences in the effects of perioperative oral administration of an NMDA-receptor antagonist (amantadine) in men undergoing radical prostatectomy. In addition, age differences in psychosocial factors and the pharmacological properties of amantadine and morphine will be measured to control for, and clarify, their contribution to the differences found.

Ethics approval

Ethics approval received from the University Health Network Research Ethics Board, Toronto, Ontario on the 12th November 2003.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Postoperative pain in radical prostatectomy

Intervention

Amantadine versus Placebo comparison.

Trial details received: 12 September 2005

Intervention type

Drug

Phase

Not Specified

Drug names

Amantadine

Primary outcome measures

Hyperalgesia and opioid consumption.

Secondary outcome measures

Assess age differences in the intensity and course of secondary hyperalgesia after surgery.

Overall trial start date

01/04/2002

Overall trial end date

31/12/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Able to read and write English
2. Age 18 - 54 years or greater than 55 years, male
3. American Society of Anesthesiologists (ASA) class 1 to 3
4. Scheduled for elective radical prostatectomy
5. Body weight between 60 and 90 kg, Body Mass Index (BMI) less than or equal to 30

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

132

Participant exclusion criteria

1. Significant Central Nervous System (CNS), respiratory, cardiac, hepatic, renal or endocrine dysfunction and/or any significant sequelae
2. Contraindications allergies to, and/or past adverse reactions to opioid analgesics or amantadine
3. History of Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) axis I disorder or cognitive dysfunction
4. History of epilepsy or other seizures
5. History of chronic pain of at least 6 months duration
6. History of long-term opioid use for chronic pain
7. History of long-term use of amantadine or other antiparkinsonian drug
8. Ingestion of antiussive medication within 48 hours before surgery
9. History of alcohol or drug dependency/abuse of at least 6 months duration

Recruitment start date

01/04/2002

Recruitment end date

31/12/2006

Locations

Countries of recruitment

Canada

Trial participating centre

Department of Anaesthesia
Toronto
M5G 2C4
Canada

Sponsor information

Organisation

University Health Network, Toronto (Canada)

Sponsor details

200 Elizabeth Street
Toronto
M5G 2C4
Canada
kfibiger@uhnres.utoronto.ca

Sponsor type

University/education

Website

http://www.uhnresearch.ca

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-52682)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes